Application Sponsors
| ANDA 062659 | SANOFI AVENTIS US | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 0 | CLAFORAN | CEFOTAXIME SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | 0 | CLAFORAN | CEFOTAXIME SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1987-01-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1995-08-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1992-07-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1992-12-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1992-11-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1992-11-09 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1996-07-31 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1996-07-31 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1996-07-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1994-01-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1994-07-14 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1996-07-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1995-12-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1995-12-20 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1998-08-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1998-03-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1998-03-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1998-07-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2000-05-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2001-02-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2001-03-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2001-08-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2001-10-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2002-06-18 | |
| LABELING; Labeling | SUPPL | 34 | AP | 2005-11-01 | |
| LABELING; Labeling | SUPPL | 35 | AP | 2005-11-01 | |
| LABELING; Labeling | SUPPL | 40 | AP | 2008-10-31 | |
| LABELING; Labeling | SUPPL | 41 | AP | 2015-11-02 | |
| LABELING; Labeling | SUPPL | 42 | AP | 2010-04-28 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 41 | Null | 15 |
CDER Filings
Accessdata Error
cder:Array
(
[0] => Array
(
[ApplNo] => 62659
[companyName] => Accessdata Error
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)